This final rule amends the regulations implementing the National Organ Transplant Act of 1984, as amended, (NOTA) pursuant to statutory requirements of the HIV Organ Policy Equity Act (HOPE Act), enacted in 2013. In accordance with the mandates of the HOPE Act, this regulation removes the current regulatory provision that requires the Organ Procurement Transplantation Network (OPTN) to adopt and use standards for preventing the acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). In its place, this regulation includes new requirements that organs from individuals infected with HIV may be transplanted only into individuals who are infected with HIV before receiving such organs and who are participating in clinical research approved by an institutional review board, as provided by regulation. The only exception to this requirement of participation in such clinical research is if the Secretary publishes a determination in the future that participation in such clinical research, as a requirement for transplants of organs from individuals infected with HIV, is no longer warranted. In addition, this regulatory change establishes that OPTN standards must ensure that any HIV-infected transplant recipients are participating in clinical research in accordance with the research criteria to be published by the Secretary. Alternately, if and when the Secretary determines that participation in such clinical research should no longer be a requirement for transplants with organs from donors infected with HIV to individuals infected with HIV, the regulation mandates that the OPTN adopt and use standards of quality, as directed by the Secretary, consistent with the law and in a way that ensures the changes will not reduce the safety of organ transplantation.

2013-10-02; vol. 78 # 191 - Wednesday, October 2, 2013

78 FR 60810 - Change to the Definition of “Human Organ” Under Section 301 of the National Organ Transplant Act of 1984

To be considered, comments should be submitted by December 2, 2013. Subject to consideration of the comments submitted, the Department intends to publish final regulations.

42 CFR Part 121

Summary

This notice seeks public comment on the proposed change in the definition of “human organ” in section 301 of the National Organ and Transplant Act of 1984, as amended, (NOTA) to explicitly incorporate hematopoietic stem cells (HSCs) within peripheral blood in the definition of “bone marrow.” This would clarify that the prohibition on transfers of human organs for valuable consideration applies to HSCs regardless of whether they were recovered directly from bone marrow (by aspiration) or from peripheral blood (by apheresis). This amendment will also conform section 301 to the provisions of the Stem Cell Research and Therapeutic Act of 2005, as amended.

HHS is issuing this final rule (herein referred to as “this rule”) to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as “a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' ” This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA).